In 2009, the U.S. Food and Drug Administration (FDA) announced that it intended to release a guidance document explaining how it will regulate industry’s use of social media to advertise products or communicate with consumers. As of today, the FDA still has not done so, and as a result, a regulatory gray area has been created, wherein industry is forced to weigh the risk of reaching out to its consumers through popular forms of social media, such as Facebook or Twitter, with no clear guidelines regarding how to do so. Despite the FDA’s failure to provide industry with any guidance on the proper use of social media in compliance with federal laws and policies, the FDA has not backed down from taking enforcement action for what it views as improper use of social media channels.

On December 11, 2012, the FDA issued a Warning Letter to AMARC Enterprises (“AMARC”) for claims made on its Facebook account that purportedly promoted its dietary supplement, PolyMVA, as a drug intended for use in the cure, mitigation, treatment, or prevention of disease. (To read the FDA’s Warning Letter to AMARC Enterprises, please click here.) Specifically, the FDA noted that the PolyMVA Facebook page “liked” a comment posted by a consumer, which stated that “PolyMVA has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously. It enabled me to keep cancer at back without the use of chemo and radiation…Thank you AMARC.” This claim was included as one of several examples of the company promoting PolyMVA “for conditions that cause the product to be a drug.”

In issuing this Warning Letter to AMARC, the FDA took an unprecedented position on the use of social media to promote or advertise FDA-regulated products. Specifically, this Warning Letter implies that the FDA views the company’s act of “liking” comments or posts on Facebook as akin to adopting or endorsing the underlying claim itself. Although the FDA did not elaborate on or specifically explain how “liking” a user’s comment constitutes drug promotion, it seems that the FDA perceives “liking” a third-party’s comment as creating an implied disease claim. The FDA’s Warning Letter sends a strong message to industry that it should be cautious in its use of Facebook’s “like” function because “liking” a comment or post could inadvertently result in closer FDA scrutiny of those consumer claims. It remains to be seen whether the FDA’s unofficial policy regarding “liking” Facebook comments will be extended to other popular social media venues, such as Twitter, where users can “re-tweet” or “favorite” a message, or Google+, where users can “+1? a post.

In a second Warning Letter to M.D.R. Fitness Corp. (“M.D.R. Fitness”) dated January 29, 2013, the FDA took the company to task regarding its website. (To read the FDA’s Warning Letter to M.D.R. Fitness, Corp., please click here.) Specifically, the FDA noted that typing well-known diseases like “cancer” or “diabetes” into a search field on the product’s website returned a list of the company’s dietary supplement products. According to the FDA’s Warning Letter, the results of this search create the implication that M.D.R. Fitness is promoting its dietary supplement products “for conditions which cause the products to be drugs” that are “intended for use in the diagnosis, cure, mitigation, treatment or prevention of such diseases.”

Even though the FDA only mentioned the company’s search engine as a passing comment in a list of other deficiencies, this statement has the potential to have significant effects on the regulation of industry. The FDA’s Warning Letter suggests that manufacturers can be held responsible for any associations consumers may make between a disease and a dietary supplement, including any information generated through a search engine. It is unclear whether the company’s search function strategically manipulated the results to include its dietary supplement products or whether the search function is built upon a dynamic tool like Google. This Warning Letter raises serious questions about the extent to which the FDA will hold manufacturers responsible for search results on their own websites and consumers’ interpretations of those search results. Based on the limited information in the M.D.R. Fitness Warning Letter, it seems likely that the FDA is now targeting manufacturers for creating implied drug claims based on no more than search results.

FDA Continues to Delay Release of Guidance on Social Media Use

In 2009, the FDA expressly stated that it planned to develop and issue guidance on the use of social media; however, the FDA has yet to issue any additional information or policies specifically related to the use of popular social media websites, such as Facebook, Twitter, or Google+. Other federal agencies, on the other hand, have recently provided some clarification on how to communicate information to the public through these social media outlets in compliance with federal laws and policies. For example, in March 2013, both the Federal Trade Commission (FTC) and Securities and Exchange Commission (SEC) released guidances that clarified how they intend to regulate the use of social media. (Please click here to access the FTC’s new guidance entitled “.com Disclosures: How to Make Effective Disclosures in Digital Advertising” and click here for more information about the SEC’s policy on the use of social media networks.) The FDA specifically stated that it has “placed developing social media guidance at the top of its work plan for 2013.” (For more information, please read the FDA News announcement here.) However, drug marketers may need to wait as late as a July 9, 2014 deadline for more detailed FDA guidance on allowable medical product promotions via the Internet and social media.

The FDA’s Warning Letters to AMARC and M.D.R. Fitness suggest that the FDA is in the process of shaping its enforcement policies regarding social media use. However, in the absence of any further guidance or information from the FDA regarding the use of social media to promote or advertise FDA-regulated products, industry will continue to face the challenge of operating these social media channels relatively blindly. Although it remains uncertain whether the FDA will continue to patrol search results on product websites or take enforcement action against companies for their use of social media prior to issuing a formal guidance document, these Warning Letters serve as notice to industry to exercise caution.

Fuerst, Ittleman, David & Joseph, PL will continue to monitor the developments in the FDA’s regulation of social media use. For more information, please contact us via e-mail at contact@fuerstlaw.com or via telephone at (305) 350-5690.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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